Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
Conditions
Brief summary
One of the targeted objectives of Healthy People 2020 is to reduce iron deficiency among women of reproductive age (WRA). Consuming foods rich in iron and/or oral iron supplementation is typically recommended to improve iron status; however, global rates of iron deficiency remain high. Thus, nutritional strategies to improve/maintain iron status are warranted. Dietary iron is found in two different forms: heme and non-heme iron. Non-heme iron is found in plant-based sources and is commonly used as a supplement and food fortificant. Absorption of non-heme iron is low compared to heme iron, which is found in animal sources, such as beef. Studies have also demonstrated that beef contains an unidentified factor that stimulates the absorption of non-heme iron. The primary objective of the proposed study is to determine the effects of incorporating daily meals containing beef or plant-based alternative with or without an iron supplement on indicators of iron status in iron-deficient WRA.
Interventions
OTHERIron supplement with a lunch meal containing beef
Participants will consume a lunch meal containing beef with an iron supplement for 8 weeks.
OTHERIron supplement with a lunch meal containing plant-based alternative
Participants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) falls within the normal weight or overweight range (18.5-29.9 kg/m\^2) * Low iron stores (serum ferritin \<25 μg/L) * Willing to refrain from smoking and \>2 alcoholic drinks/week for the duration of the study period * Willing to refrain from vitamin and mineral supplementation for the duration of the study
Exclusion criteria
* Currently smoking or vaping * Currently taking a medication that interferes with micronutrient metabolism * Unwilling to refrain from vitamin and mineral supplementation for the duration of the study * Restrictive diets (i.e., vegan or vegetarian diets) * Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.) * History of any disease or abnormality of the gastrointestinal tract including, but not limited to, diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery * Blood donation within 4 months of beginning the study * Abnormal blood clotting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iron status | Change from day 0 and day 56 | Plasma ferritin, soluble transferrin receptor, transferrin saturation, hemoglobin and hematocrit will be measured to determine iron status. Changes in measures of iron status during the intervention will be compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appetite | Change from day 0 and day 56 | Subjective appetite and satiety will be assessed before and after the lunch meal using visual analog scales. |
| Weight | Change from day 0 and day 56 | Changes in body weight during the intervention will be compared between groups. |
| Body composition | Change from day 0 and day 56 | Body composition (fat mass, fat-free mass, and total body water content) will be determined using single frequency bioimpedance spectroscopy (BIS). Changes in body composition during the intervention will be compared between groups. |
| Blood pressure | Change from day 0 and day 56 | Changes in blood pressure during the intervention will be compared between groups. |
| Profile of Mood States (POMS) | Change from day 0 and day 56 | The POMS questionnaire will be used to assess the overall mood state of the participants. Changes in the POMS during the intervention will be compared between groups. |
| Plasma zinc | Change from day 0 and day 56 | Changes in the plasma zinc during the intervention will be compared between groups. |
| Plasma vitamin B-12 | Change from day 0 and day 56 | Changes in the plasma vitamin B-12 during the intervention will be compared between groups. |
| Plasma choline | Change from day 0 and day 56 | Changes in the plasma choline during the intervention will be compared between groups. |
| Metabolic biomarkers | Change from day 0 and day 56 | Changes in blood lipids, glucose, and insulin during the intervention will be compared between groups. |
Countries
United States
Outcome results
None listed